Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStimLabs
About this trial
The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.
Eligibility criteria
Qualifiers
At least 18 years of age or older.
Diagnosis of type 1 or 2 Diabetes mellitus.
At enrollment, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 25.0 cm2 measured post debridement with the MolecuLight® Imaging Device.
The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.
Disqualifiers
Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
The potential subject must consent to using the prescribed offloading method for the duration of the study.
The potential subject must agree to attend the weekly study visits required by the protocol.
The potential subject must be willing and able to participate in the informed consent process.
Trial design
Treatments tested in this trial
- Standard of Care
- Revita
- Relese
- Cogenex
- Enverse
Treatment groups
272 Participants
are divided into 5 treatment groupsSponsors and collaborators
StimLabs
Lead sponsor
SerenaGroup, Inc.
Collaborator
Source ClinicalTrials.gov